Abstract
Background
At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe.
Method
The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors.
Results
The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.
Similar content being viewed by others
Notes
Minors are defined as people younger than 18 years. This definition of minors is according to the definition of the EU-regulation, whose defines paediatric population as the population between 0 and 18 years.
References
Baber NS (2005) Tripartite meeting. Paediatric regulatory guidelines: do they help in optimizing dose selection for children? Brit J Clin Pharmacol 59:6660–6662
Bodenheimer T (2000) Uneasy alliance–clinical investigators and the pharmaceutical industry. N Engl J Med 342(20):1539–1544
Bücheler R, Schwab M, Mörike K, Kalchthaler B, Mohr H, Schröder H, Schwoerer P, Gleiter CH (2002) Off-label prescribing to outpatient children. Brit Med J 324:1311–1312
Commission of the European Communities (2004) Proposal for a Regulation of the European Parliament and the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (presented by the Commission) {SEC(2004) 1144} COM(2004) 599 final 2004/0217 (COD), Brussels, 29.9.2004
Commission of the European Communities (2005) Amended proposal for a Regulation of the European Parliament and the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty), COM(2005) 577 final, 2004/0217 (COD), Brussels, 10.11.2005
Commission of the European Communities (2006) Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council with a view to the adoption of a regulation on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, COM(2006) 118 final, 2004/0217(COD), Brussels, 13.3.2006
Conroy S, Choonara I, et al. (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European network for drug investigation in children. Brit Med J 320(7227):79–82
EMEA (2006) Paediatric Working Party (PEG) Work programme for 2006, EMEA/CHMP/406990/2005, http://www.emea.eu.int/pdfs/human/peg/40699005en.pdf (access verified 22 June 2006)
Entorf H, Fegert JM, et al. (2004) Children in need of medical innovation, ZEW Zentrum für Europäische Wirtschaftsforschung GmbH:28
European Commission (2001) Directive 2001/20/EC Official Journal of the European Communities L 121/34
Fegert JM, Kölch M, et al. (2003) Sichere und wirksame Arzneimittel auch für Kinder. Z Rechtspol 36(12):446–450
Food and Drug Administration (2003): Approved moieties to which FDA has granted pediatric exclusivity for pediatric studies under section 505A of the Federal Food, Drug and Cosmetic Act. Available at: http://www.fda.gov/cder/pediatric/exgrant.htm, accessed July 19, 2006
Grieve J, Tordoff J, Reith D, Norris P (2005) Effect of the pediatric exclusivity provision on children’s access to medicines. Brit J Clin Pharmacol 59:(6) 730–735
Ian CK, Wong FMCB, Paramala JS, Macey LM (2004) Use of selective serotonin reuptake inhibitors in children and adolescents. Drug Safety 27(13):991–1000
Insel T, Nakamura (2006) The value and limitations of large practical clinical trials in informing practice: The NIMH Perspective; Program from 46th Annual Meeting NCDEU, Boca
Klein DF (2006) The flawed basis for FDA post-marketing safety decisions: the example of antidepressants and children. Neuropsychopharmacology 31:689–699
Knöppel C, Klinger O, Soergel M, Seyberth HW, Leonhardt A (2000) Anwendung von Medikamenten außerhalb der Zulassung oder ohne Zulassung bei Kindern. Monatschr Kinderheilkd 148:904–908
Kölch M, Lippert HD, Fegert JM (2006). Die Auswirkungen der 12. und der 14. Novelle zum AMG auf die Forschung mit Arzneimitteln für Kinder. Eine Übersicht zu den Neuregelungen, Zeitschrift für Kinder- und Jugendpsychiatrie. Z Kinder Jugendpsychiatr 34(2):117–126
Lieberman JA, Stroup TS, et al. (2005) Effectiveness of antipsychotic drugs in patients with schizophrenia (CATIE-study). N Engl J Med 353(12):1209–1223
March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. : JAMA. 2004 Aug 18;292(7):807–820
MTA Cooperative Group (1999) A 14-month randomized clinical trial of treatment strategies for attention deficit/hyperactive disorder. Arch Gen Psychiatry 56, 1073–1086
Rose K (2005) Better medicines for children- where are we and where do we want to be? Brit J Clin Pharmacol 06/2005 59(6):657
Schubert Silvia, Lippert Hans-Dieter, Fegert Jörg M, Kölch Michael (2006) Industrieunabhängige Forschung an Kindern und die 12. Novelle des Arzneimittelgesetzes Eine Studie zum Vergleich klinischer Prüfungen vor und nach der 12. Novelle des Arzneimittelgesetzes ( = A comparison of industry sponsored and investigator initiated trials in children before and after the 12th amendment of German drug law) Monatschrift Kinderheilkunde (in press)
Seyberth HW (2006) Zukünftige Anforderungen aus pädiatrischer Sicht ( = future requirements on the Regulation – the point of view of paediatrics lecture workshop European Regulation on medicinal products for paediatric use in Germany, impacts on paediatrics in Germany, 25.04.2006, Mainz
Spencer T, Biederman J, Wilens T, Prince J, Hatch M, Jones J, Harding M, Faraone SV, Seidman L (1998) Effectiveness and tolerability of tomoxetine in adults with attention deficit hyperactivity disorder. Am J Psychiatry 155:S693–S695
Sudhop T (2006) Voraussetzungen und Durchführung pädiatrischer klinischer Prüfungen aus Sicht einer Bundesoberbehörde ( = Prerequisities and conduct of clinical trials - the point of view of a regulation authority), lecture workshop European Regulation on medicinal products for paediatric use in Germany, impacts on paediatrics in Germany, 25.04.2006, Mainz
Tan J, Fegert JM (2004) Capacity and competence in child and adolescent psychiatry. Health Care Anal 12(4):285–294
Vitiello B, Heiligenstein JH, et al. (2004) The interface between publicly funded and industry-funded research in pediatric psychopharmacology: opportunities for integration and collaboration. Biol Psychiatry 56:3–9
Werner E. (2006) Europäische Kinderarzneimittelverordnung ( = European Regulation on medicinal products for paediatric use), lecture workshop European Regulation on medicinal products for paediatric use in Germany, impacts on paediatrics in Germany, 25.04.2006, Mainz
Zito JM, Derivan AT, Greenhill L (2004) Making research data available: an ethical imperative demonstrated by the SSRI debacle. J Am Acad Child Adoles Psychiatry 43(5):512–514
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Kölch, M., Schnoor, K. & Fegert, J. The EU-regulation on medicinal products for paediatric use. Eur Child Adolesc Psychiatry 16, 229–235 (2007). https://doi.org/10.1007/s00787-006-0594-8
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00787-006-0594-8